{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T13:15:39Z","timestamp":1793798139852,"version":"4.6.1"},"reference-count":40,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2025,8,7]],"date-time":"2025-08-07T00:00:00Z","timestamp":1754524800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Eisai Co. Ltd., Tokyo, Japan"},{"name":"Oxford PharmaGenesis Inc., Wilmington, DE, USA"},{"name":"Eisai Inc., Nutley, NJ, USA"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,11,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>This Phase 2 study (NCT04238715) evaluated the efficacy\/safety of tasurgratinib 140\u00a0mg daily in patients with cholangiocarcinoma (CCA) and fibroblast growth factor receptor (FGFR) 2 fusions\/rearrangements.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Eligible Japanese and Chinese patients who had surgically unresectable, advanced, or metastatic CCA and had received \u22651 prior gemcitabine-based combination chemotherapy regimen were included and treated with oral tasurgratinib 140\u00a0mg daily. The primary endpoint was objective response rate (ORR); the study was considered successful if the lower limit of the ORRs 90% CI was &amp;gt;15%. Secondary endpoints included duration of response and safety. FGFR2 fusions\/rearrangements were confirmed by fluorescence in situ hybridization performed in central laboratories. Tumor responses were measured every 8\u00a0weeks by Response Evaluation Criteria in Solid Tumors version 1.1 per independent imaging review.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Sixty-three patients were treated; 23 (37%) had received 1 prior regimen, all others had received \u22652. By the data cutoff date (15 March 2023), the ORR was 30.2% (two-sided 90% CI: 20.7\u201341.0). The median duration of response for responders was 5.6\u00a0months (95% CI: 3.7\u20139.3; range: 1.0+ to 14.8+). Sixty-one patients (97%) had \u22651 treatment-related treatment-emergent adverse event; 18 patients (29%) had \u22651 grade \u22653 treatment-related treatment-emergent adverse events. Four patients (6%) had a fatal adverse event, none were considered treatment-related. Tasurgratinib had promising antitumor activity in patients with CCA harboring FGFR2 fusions or rearrangements after \u22651 prior gemcitabine-based chemotherapy regimen.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The primary endpoint (ORR) met the study\u2019s predefined success criteria. Tasurgratinib had a manageable safety profile consistent with previous reports and the known pharmacological profile of FGFR inhibitors.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jjco\/hyaf119","type":"journal-article","created":{"date-parts":[[2025,8,6]],"date-time":"2025-08-06T11:36:50Z","timestamp":1754480210000},"page":"1229-1236","source":"Crossref","is-referenced-by-count":7,"title":["Tasurgratinib (E7090) for cholangiocarcinoma with fibroblast growth factor receptor 2 fusions\/rearrangements: a multicenter, open-label, Phase 2 study"],"prefix":"10.1093","volume":"55","author":[{"given":"Lin","family":"Shen","sequence":"first","affiliation":[{"name":"State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Cell & Gene Therapy for Solid Tumor, Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute , 52 Fucheng Road, Haidian District, Beijing, 100142 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